Trial Outcomes & Findings for Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia (NCT NCT03397134)

Last Updated: 2023-04-28

Results Overview

The Marder negative symptoms factor score (NSFS) derived from the complete Positive and Negative Syndrome Scale (PANSS) has been the most frequently used scale in schizophrenia clinical studies focusing on negative symptoms The PANSS measures comprehensive psychiatric symptoms, including positive, negative, and general symptoms. The full PANSS rates the patient on 30 different symptoms from 1 (absent) to 7 (extreme) based on an interview as well as reports of family members or primary care hospital workers. The NSFS consists of the sum of the negative symptom PANSS items N1, N2, N3, N4, N6, G7, and G16 (minimum score = 7; maximum score = 49). Higher scores indicate more severe symptoms.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

515 participants

Primary outcome timeframe

Baseline, Week 2, Week 4, Week 8, and Week 12

Results posted on

2023-04-28

Participant Flow

During the double-blind period, 857 patients were screened in the study, and 515 patients were randomized to receive treatment, including 172 patients in the placebo group and 343 patients in the Roluperidone group. Two patients who failed to meet eligibility criteria during screening, were randomized prematurely to the 32 mg Roluperidone group but were discontinued prior to receiving any study drug. Therefore, the total number of participants started is 513.

Participant milestones

Participant milestones
Measure	Placebo in Double Blind to Roluperidone 32 mg in Open Label Placebo administered in double-blind period of study then to Roluperidone 32 mg during open-label extension period of study. Placebo administered as a single dose once daily. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Placebo in Double Blind to Roluperidone 64 mg in Open Label Placebo administered in double-blind period of study then to Roluperidone 64 mg during open-label extension period of study. Placebo administered as a single dose once daily. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Roluperidone 32 mg at Any Time Roluperidone 32 mg for entire study. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Roluperidone 64 mg at Any Time Roluperidone 64 mg for entire study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Placebo in Double Blind Placebo in double-blind period of study. Placebo Oral Tablet: Placebo administered as a single dose once daily.
Double Blind STARTED	0	0	170	171	172
Double Blind COMPLETED	0	0	107	104	122
Double Blind NOT COMPLETED	0	0	63	67	50
Open-Label Extension STARTED	59	63	107	104	0
Open-Label Extension COMPLETED	35	36	72	59	0
Open-Label Extension NOT COMPLETED	24	27	35	45	0
Whole Study STARTED	0	0	229	234	50
Whole Study COMPLETED	0	0	107	95	0
Whole Study NOT COMPLETED	0	0	122	139	50

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study to Evaluate Efficacy and Safety of Roluperidone (MIN-101) in Adult Patients With Negative Symptoms of Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Roluperidone 64 mg n=171 Participants Roluperidone 64 mg for the double-blind period. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Roluperidone 32 mg n=170 Participants Roluperidone 32 mg for the double-blind period. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Placebo n=172 Participants Placebo for the double-blind period. Placebo Oral Tablet: Placebo administered as a single dose once daily.	Total n=513 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 9.3 • n=5 Participants	41 years STANDARD_DEVIATION 9.4 • n=7 Participants	41 years STANDARD_DEVIATION 8.7 • n=5 Participants	41 years STANDARD_DEVIATION 9.1 • n=4 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	64 Participants n=7 Participants	66 Participants n=5 Participants	198 Participants n=4 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	106 Participants n=7 Participants	106 Participants n=5 Participants	315 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	167 Participants n=5 Participants	165 Participants n=7 Participants	169 Participants n=5 Participants	501 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants	57 Participants n=4 Participants
Race (NIH/OMB) White	151 Participants n=5 Participants	147 Participants n=7 Participants	152 Participants n=5 Participants	450 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	27 participants n=5 Participants	27 participants n=7 Participants	27 participants n=5 Participants	81 participants n=4 Participants
Region of Enrollment Bulgaria	36 participants n=5 Participants	37 participants n=7 Participants	40 participants n=5 Participants	113 participants n=4 Participants
Region of Enrollment Georgia	5 participants n=5 Participants	5 participants n=7 Participants	2 participants n=5 Participants	12 participants n=4 Participants
Region of Enrollment Israel	0 participants n=5 Participants	4 participants n=7 Participants	2 participants n=5 Participants	6 participants n=4 Participants
Region of Enrollment Moldova	6 participants n=5 Participants	8 participants n=7 Participants	5 participants n=5 Participants	19 participants n=4 Participants
Region of Enrollment Poland	6 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants	19 participants n=4 Participants
Region of Enrollment Romania	19 participants n=5 Participants	18 participants n=7 Participants	13 participants n=5 Participants	50 participants n=4 Participants
Region of Enrollment Ukraine	72 participants n=5 Participants	66 participants n=7 Participants	75 participants n=5 Participants	213 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12

Population: mITT population

Outcome measures

Outcome measures
Measure	Roluperidone 32 mg n=167 Participants Roluperidone 32 mg for the double-blind period. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Roluperidone 64 mg n=162 Participants Roluperidone 64 mg for the double-blind period. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Placebo n=167 Participants Placebo for the double-blind period. Placebo Oral Tablet: Placebo administered as a single dose once daily.	Roluperidone 64 mg at Any Time Roluperidone 64 mg for entire study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.
Change From Baseline to Week 12 in PANSS Marder Negative Symptoms Factor Score (NSFS) Baseline	25.2 score on a scale Standard Deviation 3.43	25.3 score on a scale Standard Deviation 3.26	24.3 score on a scale Standard Deviation 3.01	—
Change From Baseline to Week 12 in PANSS Marder Negative Symptoms Factor Score (NSFS) Change from Baseline to Week 2	-1.2 score on a scale Standard Deviation 2.22	-1.7 score on a scale Standard Deviation 2.47	-1.2 score on a scale Standard Deviation 2.46	—
Change From Baseline to Week 12 in PANSS Marder Negative Symptoms Factor Score (NSFS) Change from Baseline to Week 4	-2.6 score on a scale Standard Deviation 2.57	-2.8 score on a scale Standard Deviation 2.92	-1.8 score on a scale Standard Deviation 2.99	—
Change From Baseline to Week 12 in PANSS Marder Negative Symptoms Factor Score (NSFS) Change from Baseline to Week 8	-3.4 score on a scale Standard Deviation 3.49	-3.8 score on a scale Standard Deviation 3.32	-2.8 score on a scale Standard Deviation 3.44	—
Change From Baseline to Week 12 in PANSS Marder Negative Symptoms Factor Score (NSFS) Change from Baseline to Week 12	-3.7 score on a scale Standard Deviation 3.20	-4.5 score on a scale Standard Deviation 3.85	-3.5 score on a scale Standard Deviation 3.97	—

SECONDARY outcome

Timeframe: Baseline, Week 4, Week 8, and Week 12

Population: mITT population

The PSP scale is a validated clinician-rated scale that measures personal and social functioning in 4 domains: socially useful activities (eg, work and study), personal and social relationships, self care, and disturbing and aggressive behaviors. It is a reliable, quick measure of personal and social functioning of patients with schizophrenia and can be used on patients in the acute and stable stage. PSP is a 100-point scale, divided into 10 equal intervals. The score is based on the assessment of a patient's performance in the 4 domains. Lower scores of 1 to 30 reflected poor functioning that the patient required intensive support or supervision; scores of 31 to 60 reflected varying degrees of disability; and scores of 71 to 100 reflected absence of disability or only mild difficulties.

Outcome measures

Outcome measures
Measure	Roluperidone 32 mg n=167 Participants Roluperidone 32 mg for the double-blind period. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Roluperidone 64 mg n=162 Participants Roluperidone 64 mg for the double-blind period. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Placebo n=167 Participants Placebo for the double-blind period. Placebo Oral Tablet: Placebo administered as a single dose once daily.	Roluperidone 64 mg at Any Time Roluperidone 64 mg for entire study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.
Change From Baseline to Week 12 in Personal and Social Performance (PSP) Baseline	52.7 score on a scale Standard Deviation 12.28	53.0 score on a scale Standard Deviation 10.60	52.9 score on a scale Standard Deviation 11.02	—
Change From Baseline to Week 12 in Personal and Social Performance (PSP) Change from Baseline to Week 4	1.6 score on a scale Standard Deviation 6.10	3.2 score on a scale Standard Deviation 6.30	1.2 score on a scale Standard Deviation 5.92	—
Change From Baseline to Week 12 in Personal and Social Performance (PSP) Change from Baseline to Week 8	3.6 score on a scale Standard Deviation 7.09	5.0 score on a scale Standard Deviation 6.76	3.1 score on a scale Standard Deviation 7.82	—
Change From Baseline to Week 12 in Personal and Social Performance (PSP) hange from Baseline to Week 12	4.6 score on a scale Standard Deviation 7.98	6.2 score on a scale Standard Deviation 8.67	4.2 score on a scale Standard Deviation 7.48	—

SECONDARY outcome

Timeframe: Baseline, Week 2, Week 4, Week 8, and Week 12

Population: Intent to Treat (ITT)

The Clinical Global Impression of Severity (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients

Outcome measures

Outcome measures
Measure	Roluperidone 32 mg n=170 Participants Roluperidone 32 mg for the double-blind period. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Roluperidone 64 mg n=171 Participants Roluperidone 64 mg for the double-blind period. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Placebo n=172 Participants Placebo for the double-blind period. Placebo Oral Tablet: Placebo administered as a single dose once daily.	Roluperidone 64 mg at Any Time Roluperidone 64 mg for entire study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.
Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) Baseline	4.0 score on a scale Standard Deviation 0.62	4.0 score on a scale Standard Deviation 0.61	4.0 score on a scale Standard Deviation 0.58	—
Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) Change from Baseline to Week 2	-0.1 score on a scale Standard Deviation 0.44	-0.1 score on a scale Standard Deviation 0.54	-0.1 score on a scale Standard Deviation 0.50	—
Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) Change from Baseline to Week 4	-0.2 score on a scale Standard Deviation 0.49	-0.3 score on a scale Standard Deviation 0.55	-0.1 score on a scale Standard Deviation 0.44	—
Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) Change from Baseline to Week 8	-0.3 score on a scale Standard Deviation 0.61	-0.4 score on a scale Standard Deviation 0.68	-0.2 score on a scale Standard Deviation 0.60	—
Change From Baseline to Week 12 in Clinical Global Impression of Severity (CGI-S) Change from Baseline to Week 12	-0.4 score on a scale Standard Deviation 0.68	-0.4 score on a scale Standard Deviation 0.67	-0.3 score on a scale Standard Deviation 0.63	—

SECONDARY outcome

Timeframe: Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period")

Population: Safety Population

Laboratory abnormalities were determined using pre-defined normal ranges. Clinical laboratory values were considered potentially clinically significant (PCS) for select parameters of hematology, chemistry, and urinalysis. The number and percentage of patients experiencing PCS laboratory abnormalities post-baseline were summarized by treatment group.

Outcome measures

Outcome measures
Measure	Roluperidone 32 mg n=229 Participants Roluperidone 32 mg for the double-blind period. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Roluperidone 64 mg n=234 Participants Roluperidone 64 mg for the double-blind period. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Placebo n=172 Participants Placebo for the double-blind period. Placebo Oral Tablet: Placebo administered as a single dose once daily.	Roluperidone 64 mg at Any Time Roluperidone 64 mg for entire study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.
Number of Participants With Potentially Clinically Significant Laboratory Values (Whole Study Period; Safety Population) Low potentially clinically significant laboratory values	43 Participants	37 Participants	18 Participants	—
Number of Participants With Potentially Clinically Significant Laboratory Values (Whole Study Period; Safety Population) High potentially clinically significant laboratory values	51 Participants	48 Participants	21 Participants	—

SECONDARY outcome

Timeframe: Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period")

Population: Safety Population

QTcF values were tabulated for their absolute values and tabulated relative to Baseline measurements in order to detect individual QTcF changes. The number and percentage of patients who met criteria for potentially clinically significant (PCS) values were summarized.

Outcome measures

Outcome measures
Measure	Roluperidone 32 mg n=229 Participants Roluperidone 32 mg for the double-blind period. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Roluperidone 64 mg n=234 Participants Roluperidone 64 mg for the double-blind period. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Placebo n=172 Participants Placebo for the double-blind period. Placebo Oral Tablet: Placebo administered as a single dose once daily.	Roluperidone 64 mg at Any Time Roluperidone 64 mg for entire study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.
Number of Participants With Potentially Clinically Significant ECG Parameters (Whole Study Period; Safety Population) Highest absolute QTcF interval > 500 msec	0 Participants	2 Participants	0 Participants	—
Number of Participants With Potentially Clinically Significant ECG Parameters (Whole Study Period; Safety Population) Highest absolute QTcF interval > 450 -480 msec	10 Participants	24 Participants	1 Participants	—
Number of Participants With Potentially Clinically Significant ECG Parameters (Whole Study Period; Safety Population) Highest absolute QTcF interval > 480 -500 msec	0 Participants	2 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period")

Population: Safety Population

The number and percentage of patients with any potentially clinically significant (PCS) vital sign (systolic blood pressure, diastolic blood pressure, heart rate/pulse rate, temperature) occurring post-Baseline were summarized.

Outcome measures

Outcome measures
Measure	Roluperidone 32 mg n=229 Participants Roluperidone 32 mg for the double-blind period. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Roluperidone 64 mg n=234 Participants Roluperidone 64 mg for the double-blind period. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Placebo n=172 Participants Placebo for the double-blind period. Placebo Oral Tablet: Placebo administered as a single dose once daily.	Roluperidone 64 mg at Any Time Roluperidone 64 mg for entire study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.
Number of Participants With Potentially Clinically Significant Vital Signs (Whole Study Period; Safety Population)	37 Participants	28 Participants	20 Participants	—

SECONDARY outcome

Timeframe: Study Baseline Day -1, Active Baseline last assessment on placebo at Week 12, as appropriate, Weeks 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 54. Active Baseline=last assessment before receiving Roluperidone.

Population: Safety Population

AIMS is rating scale that was designed to measure tardive dyskinesia (TD). For the scoring, the AIMS scale has 14 items. The first 10 items (under categories of Facial and Oral Movements, Extremity Movements, Trunk Movements, and Global Judgements) are rated from 0 (none) to 4 (severe); the remaining 4 items (Dental Status) are rated "yes" and "no" and not counted. The analysis is limited to items 1 to 10, with each rated from 0 to 4. The total score is the sum of all 10 items and with values ranging from 0 to 40. For the analysis, the observed composite movement (total) score will be summarized by treatment group and study visit. Higher scores imply worse outcome.

Outcome measures

Outcome measures
Measure	Roluperidone 32 mg n=86 Participants Roluperidone 32 mg for the double-blind period. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Roluperidone 64 mg n=86 Participants Roluperidone 64 mg for the double-blind period. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Placebo n=170 Participants Placebo for the double-blind period. Placebo Oral Tablet: Placebo administered as a single dose once daily.	Roluperidone 64 mg at Any Time n=171 Participants Roluperidone 64 mg for entire study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Week 36	0.1 score on a scale Standard Deviation 0.69	0.1 score on a scale Standard Deviation 0.63	0.4 score on a scale Standard Deviation 1.29	0.2 score on a scale Standard Deviation 1.48
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Study Baseline	0.2 score on a scale Standard Deviation 1.23	0.1 score on a scale Standard Deviation 0.62	0.4 score on a scale Standard Deviation 1.40	0.3 score on a scale Standard Deviation 1.04
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Active Baseline	0.2 score on a scale Standard Deviation 1.45	0.1 score on a scale Standard Deviation 0.52	0.4 score on a scale Standard Deviation 1.20	0.3 score on a scale Standard Deviation 1.15
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Week 16	0.2 score on a scale Standard Deviation 0.88	0.1 score on a scale Standard Deviation 0.56	0.5 score on a scale Standard Deviation 1.38	0.2 score on a scale Standard Deviation 1.18
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Week 20	0.1 score on a scale Standard Deviation 0.50	0.1 score on a scale Standard Deviation 0.56	0.4 score on a scale Standard Deviation 1.60	0.2 score on a scale Standard Deviation 1.06
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Week 24	0.1 score on a scale Standard Deviation 0.51	0.1 score on a scale Standard Deviation 0.57	0.4 score on a scale Standard Deviation 1.31	0.2 score on a scale Standard Deviation 1.37
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Week 28	0.1 score on a scale Standard Deviation 0.52	0.1 score on a scale Standard Deviation 0.59	0.4 score on a scale Standard Deviation 1.30	0.2 score on a scale Standard Deviation 1.38
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Week 32	0.1 score on a scale Standard Deviation 0.55	0.1 score on a scale Standard Deviation 0.60	0.4 score on a scale Standard Deviation 1.19	0.2 score on a scale Standard Deviation 1.45
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Week 40	0.1 score on a scale Standard Deviation 0.56	0.1 score on a scale Standard Deviation 0.63	0.3 score on a scale Standard Deviation 1.06	0.3 score on a scale Standard Deviation 1.53
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Week 44	0.1 score on a scale Standard Deviation 0.33	0.0 score on a scale Standard Deviation 0.16	0.3 score on a scale Standard Deviation 1.17	0.1 score on a scale Standard Deviation 0.40
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Week 48	0.1 score on a scale Standard Deviation 0.36	0.2 score on a scale Standard Deviation 0.59	0.4 score on a scale Standard Deviation 1.38	0.3 score on a scale Standard Deviation 1.57
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Week 52	0.1 score on a scale Standard Deviation 0.33	0.0 score on a scale Standard Deviation 0.17	0.3 score on a scale Standard Deviation 1.31	0.3 score on a scale Standard Deviation 1.63
Safety Assessment - Abnormal Involuntary Movement Scale (AIMS) Week 54	0.1 score on a scale Standard Deviation 0.34	0.0 score on a scale Standard Deviation 0.17	0.5 score on a scale Standard Deviation 1.55	0.3 score on a scale Standard Deviation 1.63

SECONDARY outcome

Timeframe: Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, and Week 12

Population: Safety Population

The BARS is a multiple-choice questionnaire that clinicians used to provide an assessment of akathisia. The BARS scale has 3 items that are rated from 0 (absence/no distress) to 3 (most severe). The BARS rating scale is scored by summing the scales for Objective Akathisia, Subjective Awareness of Restlessness and Subjective Distress Related to Restlessness yielding a total score ranging from 0 to 9. The Total score, which has a possible range from 0-9, is reported. Higher scores imply worse outcome.

Outcome measures

Outcome measures
Measure	Roluperidone 32 mg n=170 Participants Roluperidone 32 mg for the double-blind period. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Roluperidone 64 mg n=171 Participants Roluperidone 64 mg for the double-blind period. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Placebo n=172 Participants Placebo for the double-blind period. Placebo Oral Tablet: Placebo administered as a single dose once daily.	Roluperidone 64 mg at Any Time Roluperidone 64 mg for entire study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.
Safety Assessments - Barnes Akathisia Rations Scale (BARS) Baseline	0.1 score on a scale Standard Deviation 0.39	0.1 score on a scale Standard Deviation 0.42	0.1 score on a scale Standard Deviation 0.39	—
Safety Assessments - Barnes Akathisia Rations Scale (BARS) Week 1	0.1 score on a scale Standard Deviation 0.49	0.1 score on a scale Standard Deviation 0.39	0.1 score on a scale Standard Deviation 0.34	—
Safety Assessments - Barnes Akathisia Rations Scale (BARS) Week 2	0.2 score on a scale Standard Deviation 0.55	0.1 score on a scale Standard Deviation 0.47	0.1 score on a scale Standard Deviation 0.41	—
Safety Assessments - Barnes Akathisia Rations Scale (BARS) Week 3	0.1 score on a scale Standard Deviation 0.52	0.1 score on a scale Standard Deviation 0.43	0.1 score on a scale Standard Deviation 0.32	—
Safety Assessments - Barnes Akathisia Rations Scale (BARS) Week 4	0.1 score on a scale Standard Deviation 0.41	0.1 score on a scale Standard Deviation 0.41	0.1 score on a scale Standard Deviation 0.32	—
Safety Assessments - Barnes Akathisia Rations Scale (BARS) Week 8	0.1 score on a scale Standard Deviation 0.40	0.1 score on a scale Standard Deviation 0.44	0.0 score on a scale Standard Deviation 0.27	—
Safety Assessments - Barnes Akathisia Rations Scale (BARS) Week 12	0.1 score on a scale Standard Deviation 0.46	0.1 score on a scale Standard Deviation 0.37	0.0 score on a scale Standard Deviation 0.22	—

SECONDARY outcome

Timeframe: Study Baseline Day -1, Active Baseline last assessment on placebo at Week 12, as appropriate, Weeks 13, 14, 15, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 54. Active Baseline=last assessment before receiving Roluperidone.

Population: Safety Population

The S-AS is an established reliable and valid rating scale that measures drug-induced extrapyramidal syndromes using 10 items rated from 0 = not present to 4 = extremely severe. It consisted of 1 item measuring gait (hypokinesia), 6 items measuring rigidity (arm dropping, shoulder shacking, elbow rigidity, wrist rigidity, leg pendulousness, and head dropping) and 3 items measuring glabella tap, tremor, and salivation. As such, the range of scores was 0 to 40, with increased scores indicating increased severity.

Outcome measures

Outcome measures
Measure	Roluperidone 32 mg n=86 Participants Roluperidone 32 mg for the double-blind period. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Roluperidone 64 mg n=86 Participants Roluperidone 64 mg for the double-blind period. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Placebo n=170 Participants Placebo for the double-blind period. Placebo Oral Tablet: Placebo administered as a single dose once daily.	Roluperidone 64 mg at Any Time n=171 Participants Roluperidone 64 mg for entire study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 24	0.1 score on a scale Standard Deviation 0.40	0.1 score on a scale Standard Deviation 0.52	0.6 score on a scale Standard Deviation 1.56	0.5 score on a scale Standard Deviation 1.73
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 44	0.3 score on a scale Standard Deviation 0.77	0.1 score on a scale Standard Deviation 0.35	0.6 score on a scale Standard Deviation 1.56	0.3 score on a scale Standard Deviation 0.82
Safety Assessments -Simpson-Angus Scale (S-AS) Score Study Baseline	0.4 score on a scale Standard Deviation 0.80	0.5 score on a scale Standard Deviation 1.25	0.8 score on a scale Standard Deviation 2.18	0.6 score on a scale Standard Deviation 1.53
Safety Assessments -Simpson-Angus Scale (S-AS) Score Active Baseline	0.3 score on a scale Standard Deviation 0.83	0.1 score on a scale Standard Deviation 0.48	0.8 score on a scale Standard Deviation 2.10	0.5 score on a scale Standard Deviation 1.44
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 13	0.2 score on a scale Standard Deviation 0.63	0.2 score on a scale Standard Deviation 0.60	0.8 score on a scale Standard Deviation 1.84	0.3 score on a scale Standard Deviation 1.04
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 14	0.3 score on a scale Standard Deviation 0.81	0.2 score on a scale Standard Deviation 0.64	0.7 score on a scale Standard Deviation 1.77	0.4 score on a scale Standard Deviation 1.56
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 15	0.2 score on a scale Standard Deviation 0.48	0.2 score on a scale Standard Deviation 0.64	0.7 score on a scale Standard Deviation 1.74	0.5 score on a scale Standard Deviation 1.61
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 16	0.1 score on a scale Standard Deviation 0.34	0.1 score on a scale Standard Deviation 0.52	0.7 score on a scale Standard Deviation 1.68	0.5 score on a scale Standard Deviation 1.63
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 20	0.1 score on a scale Standard Deviation 0.33	0.1 score on a scale Standard Deviation 0.52	0.6 score on a scale Standard Deviation 1.65	0.5 score on a scale Standard Deviation 1.64
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 28	0.2 score on a scale Standard Deviation 0.48	0.1 score on a scale Standard Deviation 0.53	0.7 score on a scale Standard Deviation 1.65	0.3 score on a scale Standard Deviation 1.66
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 32	0.2 score on a scale Standard Deviation 0.49	0.1 score on a scale Standard Deviation 0.54	0.6 score on a scale Standard Deviation 1.60	0.4 score on a scale Standard Deviation 1.68
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 36	0.2 score on a scale Standard Deviation 0.50	0.1 score on a scale Standard Deviation 0.54	0.6 score on a scale Standard Deviation 1.65	0.4 score on a scale Standard Deviation 1.70
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 40	0.1 score on a scale Standard Deviation 0.30	0.1 score on a scale Standard Deviation 0.57	0.6 score on a scale Standard Deviation 1.36	0.4 score on a scale Standard Deviation 1.69
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 48	0.4 score on a scale Standard Deviation 1.52	0.1 score on a scale Standard Deviation 0.32	0.7 score on a scale Standard Deviation 1.69	0.5 score on a scale Standard Deviation 1.79
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 52	0.1 score on a scale Standard Deviation 0.35	0.1 score on a scale Standard Deviation 0.34	0.5 score on a scale Standard Deviation 1.42	0.5 score on a scale Standard Deviation 1.84
Safety Assessments -Simpson-Angus Scale (S-AS) Score Week 54	0.2 score on a scale Standard Deviation 0.49	0.2 score on a scale Standard Deviation 0.76	0.7 score on a scale Standard Deviation 1.75	0.5 score on a scale Standard Deviation 1.83

SECONDARY outcome

Population: Safety Population

Sheehan Suicidality Tracking Scale (STS) is a prospective rating scale that tracks treatment-emergent suicidal ideation and behaviors. Scoring: Each item is scored on a 5-point Likert scale from 0 (not at all) to 4 (extremely). Data from the STS can be analyzed as individual item scores, a subscore for suicidal ideation (sum of scores from items 2, 3, and 4, plus score from item 5 if ≤ 1), a subscore for suicidal behavior (sum of scores from items 6, 7, and 8, plus score from item 5 if \> 1) and the total scale score (calculated by add scores from Questions 1a (only if 1b is coded YES), + 2 through 11 + \[the highest of 12 or any row of 16\] + \[the highest of 14 or any row of 15\] + 17 + 20. Analysis: The total scale score will be summarized by treatment group and study visit. Complete data will be presented in patient data listings by treatment group and visit. The total score is the sum of all 16 questions and with values ranging from 0 to 64. Higher scores imply worse outcome.

Outcome measures

Adverse Events

Placebo in Double Blind to Roluperidone 32 mg in Open Label

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo in Double Blind to Roluperidone 64 mg in Open Label

Serious events: 5 serious events

Other events: 7 other events

Deaths: 1 deaths

Roluperidone 32 mg at Any Time

Serious events: 18 serious events

Other events: 30 other events

Deaths: 2 deaths

Roluperidone 64 mg at Any Time

Serious events: 21 serious events

Other events: 39 other events

Deaths: 1 deaths

Placebo

Serious events: 5 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo in Double Blind to Roluperidone 32 mg in Open Label n=59 participants at risk Placebo administered double blind Phase of Study then Roluperidone 32 mg during open label phase of study. Roluperidone 32 mg: Roluperidone administered as a single dose once daily	Placebo in Double Blind to Roluperidone 64 mg in Open Label n=63 participants at risk Placebo administered double blind Phase of Study then Roluperidone 64 mg during open label phase of study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily	Roluperidone 32 mg at Any Time n=229 participants at risk Roluperidone 32 mg for entire study Roluperidone 32 mg: Roluperidone administered as a single dose once daily	Roluperidone 64 mg at Any Time n=234 participants at risk Roluperidone 64 mg for entire study Roluperidone 64 mg: Roluperidone administered as a single dose once daily	Placebo n=172 participants at risk Placebo Placebo Oral Tablet: Placebo administered as a single dose once daily
Psychiatric disorders Schizophrenia	1.7% 1/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	3.9% 9/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	3.8% 9/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.58% 1/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Psychiatric disorders Agitation	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.87% 2/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.85% 2/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Psychiatric disorders Anxiety	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.6% 1/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.85% 2/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Psychiatric disorders Aggression	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.6% 1/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.43% 1/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Psychiatric disorders Psychotic symptom	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.43% 1/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.7% 3/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Psychiatric disorders Sleep Disorder	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.6% 1/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.43% 1/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.58% 1/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Psychiatric disorders Completed suicide	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Psychiatric disorders Depression	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.43% 1/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Psychiatric disorders Hallucination, auditory	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.6% 1/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.43% 1/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Psychiatric disorders Psychotic disorder	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Infections and infestations Bartholinitis	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.43% 1/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Infections and infestations Pneumonia	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Infections and infestations Pneumonia bacterial	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.6% 1/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.43% 1/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Infections and infestations Pneumonia viral	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.6% 1/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.43% 1/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.6% 1/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.85% 2/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Injury, poisoning and procedural complications Concussion	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.6% 1/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.43% 1/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Cardiac disorders Acute myocardial infarction	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Cardiac disorders Cardiac failure acute	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.44% 1/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.6% 1/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.43% 1/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Skin and subcutaneous tissue disorders Rash	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.43% 1/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.

Other adverse events

Other adverse events
Measure	Placebo in Double Blind to Roluperidone 32 mg in Open Label n=59 participants at risk Placebo administered double blind Phase of Study then Roluperidone 32 mg during open label phase of study. Roluperidone 32 mg: Roluperidone administered as a single dose once daily	Placebo in Double Blind to Roluperidone 64 mg in Open Label n=63 participants at risk Placebo administered double blind Phase of Study then Roluperidone 64 mg during open label phase of study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily	Roluperidone 32 mg at Any Time n=229 participants at risk Roluperidone 32 mg for entire study Roluperidone 32 mg: Roluperidone administered as a single dose once daily	Roluperidone 64 mg at Any Time n=234 participants at risk Roluperidone 64 mg for entire study Roluperidone 64 mg: Roluperidone administered as a single dose once daily	Placebo n=172 participants at risk Placebo Placebo Oral Tablet: Placebo administered as a single dose once daily
Psychiatric disorders Insomnia	1.7% 1/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	3.1% 7/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.7% 4/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	4.1% 7/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Psychiatric disorders Schizophrenia	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	2.6% 6/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	2.1% 5/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	2.9% 5/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Psychiatric disorders Agitation	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.7% 4/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.7% 4/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.2% 2/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Nervous system disorders Headache	1.7% 1/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	7.9% 5/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	3.5% 8/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	6.4% 15/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	2.3% 4/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
Investigations Electrocardiogram QT prolonged	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.6% 1/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.87% 2/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	2.1% 5/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	0.00% 0/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.
General disorders Asthenia	0.00% 0/59 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.6% 1/63 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	1.3% 3/229 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	2.6% 6/234 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.	2.3% 4/172 • Entire study (which includes double-blind and open-label periods) from Baseline to Week 54 (referred to as the "whole study period"). Safety population=513 patients treated across the whole study period: 172 patients received at least 1 dose of placebo \& 463 patients received at least 1 dose of roluperidone (including 229 patients who received 32 mg roluperidone \& 234 patients who received 64 mg roluperidone). Of the 172 patients who received placebo during double blind, 122 patients continued into the open-label period. Of these 122 patients, 59 patients received 32 mg roluperidone \& 63 patients received 64 mg roluperidone.

Additional Information

Senior Vice President and Head of R&D

Minerva Neurosciences

Phone: 617-600-7378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Roluperidone 32 mg n=86 Participants Roluperidone 32 mg for the double-blind period. Roluperidone 32 mg: Roluperidone administered as a single dose once daily.	Roluperidone 64 mg n=86 Participants Roluperidone 64 mg for the double-blind period. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.	Placebo n=170 Participants Placebo for the double-blind period. Placebo Oral Tablet: Placebo administered as a single dose once daily.	Roluperidone 64 mg at Any Time n=171 Participants Roluperidone 64 mg for entire study. Roluperidone 64 mg: Roluperidone administered as a single dose once daily.
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Study Baseline	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.15	0.0 score on a scale Standard Deviation 0.46	0.0 score on a scale Standard Deviation 0.08
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 12.1	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 36	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.11	0.0 score on a scale Standard Deviation 0.0
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 48	0.1 score on a scale Standard Deviation 0.49	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.12	0.0 score on a scale Standard Deviation 0.38
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Active Baseline	0.0 score on a scale Standard Deviation 0.13	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.00	0.0 score on a scale Standard Deviation 0.10
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 12.2	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 13	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.10
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 14	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 15	0.0 score on a scale Standard Deviation 0.14	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 16	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.10	0.0 score on a scale Standard Deviation 0.0
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 20	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.41
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 24	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 28	0.2 score on a scale Standard Deviation 1.44	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.11	0.0 score on a scale Standard Deviation 0.0
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 32	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 40	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.11	0.0 score on a scale Standard Deviation 0.0
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 44	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.22	0.0 score on a scale Standard Deviation 0.0
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 52	0.0 score on a scale Standard Deviation 0.17	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0
Safety Assessments - Sheehan Suicidality Tracking Scale (STS) Total Score Week 54	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0